Pre-clinical and clinical trails

Deciding whether a drug is ready for clinical trials (the so-called move from bench to bedside) involves extensive preclinical studies that yield preliminary efficacy, toxicity, pharmacokinetic and safety information. Wide doses of the drug are tested using in vitro (test tube or cell culture) and in vivo (animal) experiments, and it is also possible to perform in silico profiling using computer models of the drug–target interactions.

Much like for clinical trials, there are certain types of trials that have to be done, such as toxicology studies in most cases, and other trials that are specific to the particular study compound or question. Understanding that the goal of preclinical trials is to move into the clinical stage is key and the studies should be designed around that goal. Watch our online seminar on moving from preclinical to clinical trials.

Clinical trial phases:

The entire process of moving a drug from design to clinical trials takes 10 to 12 years on average. Let’s take a closer look at each stage to better understand what goes into early clinical development and preparation for approval of a drug.

 

 

  • drug development
  • phase I trial
  • clinical studies

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